treatment of patients with lesions in the superficial femoral and/ or popliteal arteries using kanshas paclitaxel-coated balloon catheter.

Conditions: Femoropopliteal Occlusive Disease; Peripheral Artery Disease

Summary: assessing the safety and effectiveness of the kanshas paclitaxel-coated balloon catheter in the treatment of de novo lesions in the superficial femoral (sfa) and/or popliteal arteries.

the kanshas 1 (k-1) trial investigates the inhibition of restenosis using the kanshas paclitaxel-coated balloon catheter in the treatment of de novo lesions in the superficial femoral and/or popliteal arteries. this clinical study is a prospective, multi-center, open, single-arm study. up to 50 patients will be enrolled at 2 sites in belgium and 4 sites in germany. follow-ups are scheduled before discharge, at 1 month (clinic visit or phone fu), 6 months, 1-year, 2-years (clinic visits), 3-, 4- and 5- years (clinic visits or phone fu). primary outcome measure: * freedom from device-and procedure-related death through 30 days. * freedom from target limb amputations and clinically driven target lesion revascularization through 6 months.

Eligibility criteria:
inclusion criteria: general: 1. clinically significant symptomatic leg ischemia, requiring treatment of the sfa and/or popliteal artery; 2. able and willing to provide informed consent prior to study procedures; 3. able and willing to comply with follow-up requirements; 4. rutherford clinical category of 2-4; 5. resting abi of \<0.9 or abnormal exercise abi; 6. ≥18 years old; 7. life expectancy is \>2 year; angiographic criteria: 8. cumulative lesion length ≥4 and ≤15 cm within the target vessel; cumulative lesion consists of either a single de novo lesion or multiple lesions within the 4-15 cm segment; multiple lesions require to meet all the following; * separated by a gap of ≤ 3 cm; * able to be treated as a single lesion; * total combined lesion length including 3cm gap meets requirements; 9. lesion location starts ≥2 cm distal to the common femoral bifurcation and terminates at ≥2 cm proximal to the origin of the tibio-peroneal trunk; 10. clinically and hemodynamically significant de novo stenosis (\>70% stenosis by visual estimate) or occlusion; 11. target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix; 12. successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion; 13. a patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of ipsilateral iliac lesions); note: successful ipsilateral iliac artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication. 14. at least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized; exclusion criteria: 1. pregnant or lactating females; 2. co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries; 3. significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy; 4. known intolerance to study medications, paclitaxel or contrast agents; 5. patient participating in another investigational device or drug study that has not reached the primary endpoint; 6. history of hemorrhagic stroke within 2 months; 7. previous or planned surgical or interventional procedure within 30 days of the study procedure; 8. diagnosed liver failure, renal failure, chronic kidney disease, unstable angina pectoris, or myocardial infarction within 30 days of the procedure; 9. presence of significant stenosis or occlusion of the inflow tract that cannot be successfully treated prior to study consideration. successful is defined as \<30% residual stenosis of ipsilateral iliac artery with no major complications; 10. acute thrombus in target vessel; 11. at site of target lesion, use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, brachytherapy); 12. outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥50% stenosis) may not be treated during the same procedure; 13. has in-stent restenosis in the target lesion; 14. previous treatment with a drug coated pta balloon catheter or drug eluting stent in the target vessel within 12 months of the index procedure; 15. previous peripheral bypass affecting the target limb; 16. has injuries in the target vessel, such as major flow-limiting dissection ( \> nhlbi grade c) and perforation, requiring stenting prior to enrollment; 17. obvious subintimal recanalization or intentional subintimal recanalization in the occlusive lesions; 18. presence of severe calcification in the target lesions that precludes endovascular treatment. severe calcification is defined as circumferential calcification involving ≥ 50% of vessel diameter.